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Efficacy of 8?mg lidocaine and 2?mg cetylpyridinium chloride (CPC) fixed-combination lozenges on sore throat pain intensity compared with 1?mg lidocaine and 2?mg CPC fixed-combination lozenges in subjects with sore throat due to upper respiratory tract infection: a randomized double-blind parallel-group single-dose study.

ABSTRACT: BACKGROUND:Lozenges containing lidocaine and cetylpyridinium chloride (CPC) are commonly used for the treatment of sore throat. The lidocaine acts locally to provide pain relief and the CPC has an antiseptic effect. Mebucaine CL, a well-established fixed-combination sore throat lozenge, contains 1?mg lidocaine and 2?mg CPC. Single-agent lozenges containing 8?mg lidocaine have also been demonstrated to be significantly superior to placebo in confirmatory pain intensity assessments. This study compared a new lozenge formulation, containing 8?mg lidocaine and 2?mg CPC, with the currently marketed lozenge for the treatment and relief of sore throat symptoms in subjects diagnosed with a sore throat due to an upper respiratory tract infection (URTI). METHODS:In this double-blind parallel-group study, 250 adults with a sore throat due to an URTI were randomized to receive a single lozenge containing either 8?mg lidocaine +?2?mg CPC (n?=?125) or 1?mg lidocaine +?2?mg CPC (n?=?125). The primary efficacy endpoint of the study was the change in sore throat pain intensity (STPI) between baseline (immediately pre-treatment) and the 2-h post-dose assessment, measured on a 100?mm visual analog scale. STPI was measured at baseline and regular intervals up to 240?min after the lozenge was administered (evaluated in clinic). Any difficulty in swallowing and time to onset and duration of the analgesic effect were also assessed. RESULTS:No increase in efficacy was demonstrated with the higher dose of lidocaine. The difference in the 2-h post-dose change in STPI was not statistically significant between the treatments. There was only one statistically significant difference between the treatments in all of the efficacy outcomes assessed: pain relief scores at 4?h post-dose were higher with 1?mg lidocaine +?2?mg CPC than with 8?mg lidocaine +?2?mg CPC (P?=?0.0461). The most commonly reported adverse event (AE) was a headache; the only other AE experienced by more than one subject was throat irritation. No severe adverse events were reported during the assessment period. CONCLUSIONS:The modest difference in the pattern of effectiveness between the two treatments observed in this study does not support use of the 8?mg lidocaine +?2?mg CPC lozenge. TRIAL REGISTRATION:ClinicalTrials.gov, NCT01265446 . Registered on 20 December 2010.

SUBMITTER: Donath F

PROVIDER: S-EPMC6292119 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Efficacy of 8 mg lidocaine and 2 mg cetylpyridinium chloride (CPC) fixed-combination lozenges on sore throat pain intensity compared with 1 mg lidocaine and 2 mg CPC fixed-combination lozenges in subjects with sore throat due to upper respiratory tract infection: a randomized double-blind parallel-group single-dose study.

Donath Frank F Mallefet Pascal P Garreffa Stephen S Furcha Rowland R

Trials 20181212 1

<h4>Background</h4>Lozenges containing lidocaine and cetylpyridinium chloride (CPC) are commonly used for the treatment of sore throat. The lidocaine acts locally to provide pain relief and the CPC has an antiseptic effect. Mebucaine CL, a well-established fixed-combination sore throat lozenge, contains 1 mg lidocaine and 2 mg CPC. Single-agent lozenges containing 8 mg lidocaine have also been demonstrated to be significantly superior to placebo in confirmatory pain intensity assessments. This s ...[more]

PMID: 30541606

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Project description:BackgroundAntibiotics are inappropriately prescribed to many people with sore throat. As most cases of sore throat are viral and/or self-limiting, guidelines recommend symptomatic management as first-line treatment. This paper reviews the available clinical evidence for the efficacy and safety of low-dose (8.75 mg) flurbiprofen, locally delivered to the throat for the symptomatic management of pharyngitis/sore throat.MethodA literature search was performed on 27 February 2019 using PubMed. Studies that met the following criteria were included in a narrative review: (1) studies evaluating the effectiveness of flurbiprofen for pharyngitis/sore throat; (2) randomized controlled studies; (3) locally administered formulation of study drug/comparator; and (4) flurbiprofen administered at 8.75 mg dose (single- or multiple-dose administration).ResultsA total of 17 papers were included in the review: 15 publications reporting data from nine unique clinical studies of flurbiprofen for acute pharyngitis, and two reporting studies of flurbiprofen for the prevention of postoperative sore throat (POST). Studies in acute pharyngitis demonstrated that single- and multiple-dose flurbiprofen 8.75 mg, locally administered in lozenge, spray or microgranule form, was well tolerated and provided early onset and long-lasting symptomatic relief from throat pain and soreness, sensation of swollen throat, difficulty swallowing, and other associated symptoms. This included patients with more severe symptoms, patients with confirmed Streptococcus A/C sore throat, and patients taking concomitant antibiotics. In addition, a single preoperative dose of flurbiprofen lozenge was shown to be effective for relieving early POST in patients undergoing general anesthesia.ConclusionLocally administered, low-dose flurbiprofen offers a useful first-line treatment option for symptomatic relief in patients with "uncomplicated" acute pharyngitis/sore throat associated with upper respiratory tract infection, thus potentially helping to reduce unnecessary antibiotic prescribing. It also offers an effective preoperative treatment option for the reduction of early POST severity and incidence.

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